|The following article is part of conference coverage from the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from ECTRIMS 2018.|
The rate of relapse in relapsing multiple sclerosis is significantly reduced with ozanimod in comparison with interferon β-1a, according to a study recently presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, held October 10-12, 2018, in Berlin, Germany.
This study included 2659 individuals who were randomly assigned to one of 3 treatments: ozanimod HCl 1 mg (n=880), ozanimod HCl 0.5 mg (n=890), and interferon β-1a 30 µg (n=889). Treatments were evaluated for either 1 year (SUNBEAM) or 2 years (RADIANCE). The study researchers defined relapse as neurological symptoms that were either incident or worsened for more than 1 day as well as an increase of at least 0.5 in the Expanded Disability Status Scale, at least 1 on 2 Function System scores, or at least 2 on 1 Function System score. Steroid treatment or hospitalization constituted criteria for severe relapse. A Poisson regression model with adjustments for region, study, baseline age and gadolinium-enhancing lesions at baseline was used to compare annualized relapse rates. A log-rank test was used to compare the numbers of patients who relapsed.
Overall annualized relapse rate was reduced by 42% among those using ozanimod HCl 1 mg treatments (0.18; P =.0001) and by 26% among those using ozanimod HCl 0.5 mg (0.23; P =.0001), compared with interferon β-1a (0.30). Among those who relapsed, 96% were either hospitalized or given steroid treatment. Annualized relapse rate requiring steroids or hospitalization showed a 43% reduction with ozanimod HCl 1 mg (0.15; P =.0001) and 26% with 0.5 mg (0.20; P =.0001) when compared with interferon β-1a (0.27) in adjusted post-hoc analysis. The rate of relapse requiring either steroid treatment or hospitalization was significantly lower among those treated with ozanimod HCl 1 mg (20.1%; P =.0001) and ozanimod HCl 0.5 mg (23.3%; P =.008) compared with interferon β-1a (30.7%).
The study researchers concluded that “ozanimod significantly reduced the rate of relapses, including the present definition of severe relapses, vs [interferon β-1a] in patients with [relapsing multiple sclerosis]. These data support the potential of ozanimod as an effective oral treatment to reduce the rate of relapse, including severe relapse, in patients with [relapsing multiple sclerosis].”
Disclosures: Several authors report associations and financial disclosures with pharmaceutical companies. For a full list of author disclosures, visit the reference.
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Comi G, Kappos L, Hartung HP, et al. Ozanimod reduces rates of annualised relapse requiring steroids or hospitalisation versus interferon β-1a: pooled results from two multicentre, randomised, double-blind, phase 3 studies in relapsing multiple sclerosis (SUNBEAM and RADIANCE). Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. October 10-12, 2018; Berlin, Germany. Poster P869.